Alexion Pharmaceuticals is planning to initiate a pivotal Phase 3 study of ULTOMIRIS® (ravulizumab) in amyotrophic lateral sclerosis (ALS). The 50-week global study, called CHAMPION-ALS, will evaluate approximately 350 adults across a broad patient population, and the primary endpoint will be change in ALS functional rating scale-revised (ALSFRS-R) score.
Alexion submitted an investigational new drug application for ULTOMIRIS in ALS to the FDA in the fourth quarter of 2019 and plans to initiate the Phase 3 study this quarter. more